Leveraging Extended Reality Exergaming and Telehealth to Improve Physical Activity and Health in Children With Disabilities
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Godin Leisure Time Exercise Questionnaire
研究概览
简要总结
This phase II RCT evaluates the efficacy of a telehealth-delivered extended reality (XR) exergaming intervention on physical activity, cardiometabolic health, and physical fitness in physically inactive children with cerebral palsy (ages 10 to 17). A total of 130 participants will be randomized to either a 12-week XR exergaming intervention with behavioral coaching or a non-intervention control group, followed by a 24-week sustainability phase. Aim 1 examines immediate and sustained effects on physical activity levels. Aim 2 tests effects on cardiometabolic health indicators including blood lipids, blood pressure, and glycemic markers. Aim 3 explores effects on physical fitness and perceived health. All procedures are conducted remotely via telehealth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessors will be blinded to group allocation (data entry and analysis personnel).
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medical diagnosis of cerebral palsy
- •between the ages of 10-17 years (10 years of age is the minimum requirement of the Meta Quest 3s headset, as noted by the manufacturer)
- •physician clearance to participate in moderate-intensity exercise
- •access to a Wi-Fi Internet connection in the home
- •a caregiver that is committed to supporting the child with setting up and assisting with the prescribed exergaming and managing the study activities
排除标准
- •physically active (defined as ≥150 minutes per week of moderate-to-vigorous intensity exercise in a typical week)
- •prone to photosensitive seizures
- •a classification of GMFCS level V, which we have found to preclude the ability to use the Oculus Quest hand-held controllers
- •complete blindness or deafness
- •unable to communicate in English (participant and caregiver)
研究组 & 干预措施
Extended Reality Gaming (XRG)
Immediate start of extended reality exercise program for 36 weeks.
干预措施: Extended Reality Exergaming (Behavioral)
Non-intervention Control
Continue habitual activities for 36 weeks.
结局指标
主要结局
Godin Leisure Time Exercise Questionnaire
时间窗: week 0, week 6, week 12, week 24, week 36
The GLTEQ is a 7-day recall survey. The GLTEQ will be scored using a health contribution (HC) score, which equates an HC score of ≥24 to the minimum aerobic guideline of 150 mins/week of moderate exercise.
Daily Step Count
时间窗: weeks 0-36
Steps per day, captured using the Polar Unite wrist watch.
次要结局
- Changes in C-reactive Protein (hsCRP)(week 0, week 6, week 12, week 24, week 36)
- Changes in Hemoglobin A1C(week 0, week 6, week 12, week 24, week 36)
- Changes in Fasting Insulin(week 0, week 6, week 12, week 24, week 36)
- Changes in Fasting Triglycerides(week 0, week 6, week 12, week 24, week 36)
- Changes in High-density Lipoprotein(week 0, week 6, week 12, week 24, week 36)
- Changes in Low-density Lipoprotein(week 0, week 6, week 12, week 24, week 36)
- Changes in Total Cholesterol(week 0, week 6, week 12, week 24, week 36)
- Changes in Resting Systolic Blood Pressure(week 0, week 6, week 12, week 24, week 36)
- Changes in Resting Diastolic Blood Pressure(week 0, week 6, week 12, week 24, week 36)
- 2-Minute Step Test(Week 0, Week 6, Week 12, Week 24, Week 36)
- Timed Up and Go (TUG)(Week 0, Week 6, Week 12, Week 24, Week 36)
- Hand-grip Strength Test (hand-held dynamometer)(Week 0, Week 6, Week 12, Week 24, Week 36)
- NIH PROMIS Global Health Pediatric (7 item) survey(Week 0, Week 6, Week 12, Week 24, Week 36)
- Changes in Body Weight(Week 0,Week 6, Week 12, Week 24, Week 36)
研究者
Byron Lai
Assistant Professor
University of Alabama at Birmingham